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December 2016:
New safety information is provided in the revised Prescribing Information and Medication Guide.

Important Safety Information

ABSTRAL® (fentanyl) sublingual tablets CII
ABSTRAL® (AB-stral) sublingual tablets are used to manage breakthrough pain in adults with cancer (18 years of age and older) who are already routinely taking other opioid pain medicines around-the-clock for cancer pain.

Limitations of Use:
  • Not for use in the management of acute or postoperative pain, including headache/migraine, dental pain, or in the emergency department.
  • As a part of the TIRF REMS Access program, ABSTRAL may be dispensed only to outpatients enrolled in the program. For inpatient administration of ABSTRAL (e.g., hospitals, hospices, and long-term care facilities that prescribe for inpatient use), patient and prescriber enrollment is not required.

IMPORTANT:
Do not use ABSTRAL unless you are regularly using another opioid pain medicine around-the-clock for at least one week or longer for your cancer pain and your body is used to these medicines (this means that you are opioid tolerant). You can ask your healthcare provider if you are opioid tolerant.
Keep ABSTRAL in a safe place away from children.
Get emergency medical help right away if:
  • a child takes ABSTRAL. ABSTRAL can cause an overdose and death in any child who takes it.
  • an adult who has not been prescribed ABSTRAL takes it
  • an adult who is not already taking opioids around-the-clock, takes ABSTRAL
These are medical emergencies that can cause death. If possible, try to remove ABSTRAL from the mouth.
Read the Medication Guide that comes with ABSTRAL completely before you start taking ASBTRAL, and each time you get a new prescription. Additional safety information was added to the Medication Guide in December 2016. The Medication Guide does not take the place of talking to your healthcare provider about your medical condition or your treatment. Be sure to share this important information with members of your household and other caregivers.

Abstral is:
  • A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage breakthrough pain in adults with cancer who are already routinely taking other opioid pain medicines around-the-clock for cancer pain. ABSTRAL is started only after you have been taking other opioid pain medicines and your body has become used to them (you are opioid tolerant). Do not use ABSTRAL if you are not opioid tolerant.
  • An opioid pain medicine that can put you at risk for overdose and death. Even if you take your dose correctly as prescribed you are at risk for opioid addiction, abuse, and misuse that can lead to death.
Important information about ABSTRAL:
  • Get emergency help right away if you take too much ABSTRAL (overdose). When you first start taking ABSTRAL, when your dose is changed, or if you take too much (overdose), serious life-threatening breathing problems that can lead to death may occur.
  • Taking ABSTRAL with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death.
  • Never give anyone else your ABSTRAL. They could die from taking it. Store ABSTRAL away from children and in a safe place to prevent stealing or abuse. Selling or giving away ABSTRAL is against the law.
  • If you stop taking your around-the-clock opioid pain medicine for your cancer pain, you must stop using ABSTRAL. You may no longer be opioid tolerant. Talk to your healthcare provider about how to treat your pain.
  • ABSTRAL is available only through a program called the Transmucosal Immediate Release Fentanyl (TIRF) Risk Evaluation and Mitigation Strategy (REMS) Access program.
  • To receive ABSTRAL, you must:
    • talk to your healthcare provider
    • understand the benefits and risks of ABSTRAL
    • agree to all of the instructions
    • sign the Patient-Prescriber Agreement form
  • ABSTRAL is only available at pharmacies that are part of the TIRF REMS Access program. Your healthcare provider will let you know the pharmacy closest to your home where you can have your ABSTRAL prescription filled.
  • Be very careful about taking other medicines that may make you sleepy, such as other pain medicines, anti- depressant medicines, sleeping pills, anti-anxiety medicines, antihistamines, or tranquilizers.
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

Do not take ABSTRAL if:
  • You are not opioid tolerant. Opioid tolerant means that you are already taking other opioid pain medicines around-the-clock for at least one week or longer for your cancer pain, and your body is used to these medicines.
  • You have severe asthma, trouble breathing, or other lung problems.
  • You have a bowel blockage or have narrowing of the stomach or intestines.
  • You are allergic to any of the ingredients in ABSTRAL. See the Medication Guide for a complete list of ingredients in ABSTRAL.
  • You have short-term pain that you would expect to go away in a few days, such as:
    • pain after surgery
    • headache or migraine
    • dental pain
Before taking ABSTRAL, tell your healthcare provider if you have a history of:
  • Troubled breathing or lung problems such as asthma, COPD, wheezing, or shortness of breath
  • head injury, seizures
  • slow heart rate or other heart problems
  • low blood pressure
  • mental problems [including major depression, schizophrenia or hallucinations (seeing or hearing things that are not there)]
  • problems urinating
  • liver, kidney, thyroid problems
  • pancreas or gallbladder problems
  • abuse of street or prescription drugs, alcohol addiction, or mental health problems
Tell your healthcare provider if you are:
  • pregnant or planning to become pregnant. Prolonged use of ABSTRAL during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.
  • breastfeeding. ABSTRAL passes into breast milk and may harm your baby.
  • taking prescription over-the-counter medicines, vitamins, or herbal supplements. Taking ABSTRAL with certain other medicines can cause serious side effects that could lead to death.
When taking ABSTRAL:
  • Do not change your dose. Take ABSTRAL exactly as prescribed by your healthcare provider.
  • Your healthcare provider will change the dose until you and your healthcare provider find the right dose for you.
  • Use ABSTRAL tablets whole.
  • Do not crush, split, suck, or chew ABSTRAL tablets, or swallow the tablets whole. You will get less relief for your breakthrough cancer pain.
  • Wait 30 minutes after using ABSTRAL. If there is any of the ABSTRAL tablet left in your mouth, you may drink a glass of water to help you swallow the left over medicine.
  • You must not use more than 2 doses of ABSTRAL for each episode of breakthrough cancer pain.
  • Use 1 dose of ABSTRAL for an episode of breakthrough cancer pain.
  • If your breakthrough cancer pain does not get better 30 minutes after taking the first dose of ABSTRAL, you can use only 1 more dose of ABSTRAL as instructed by your healthcare provider.
  • See the detailed Instructions for Use in the Medication Guide for information about how to use ABSTRAL.
  • If your breakthrough pain does not get better after the second dose of ABSTRAL, call your healthcare provider for instructions. Do not use another dose of ABSTRAL at this time.
  • Wait at least 4 hours before treating a new episode of breakthrough cancer pain with ABSTRAL.
  • If you only need to take 1 dose of ABSTRAL for an episode of breakthrough pain, you must wait 4 hours from the time of that dose to take a dose of ABSTRAL for a new episode of breakthrough pain.
  • If you need to use 2 doses of ABSTRAL for an episode of breakthrough pain, you must wait 4 hours after the second dose to take a dose of ABSTRAL for a new episode of breakthrough pain.
  • It is important for you to keep taking your around-the-clock opioid pain medicine while using ABSTRAL.
  • Talk to your healthcare provider if your dose of ABSTRAL does not relieve your breakthrough cancer pain. Your healthcare provider will decide if your dose of ABSTRAL needs to be changed.
  • Talk to your healthcare provider if you have more than 4 episodes of breakthrough cancer pain per day. The dose of your around-the-clock opioid pain medicine may need to be adjusted.
  • If you begin to feel dizzy, sick to your stomach, or very sleepy before the tablet is completely dissolved, rinse your mouth with water and spit the remaining pieces of the tablet into a sink or toilet right away. Rinse the sink or flush the toilet to dispose of any remaining tablet pieces.
  • Do not stop taking ABSTRAL without talking to your healthcare provider.
  • See the detailed Instructions for Use and Disposal of ABSTRAL in the Medication Guide.
  • DO NOT Drive or operate heavy machinery, until you know how ABSTRAL affects you. ABSTRAL can make you sleepy, dizzy, or lightheaded.
  • DO NOT Drink alcohol or use prescription or over-the-counter medicines that contain alcohol. Using products containing alcohol during treatment with ABSTRAL may cause you to overdose and die.
  • DO NOT Switch from ABSTRAL to other medicines that contain fentanyl without talking with your healthcare provider. The amount of fentanyl in a dose of ABSTRAL is not the same as the amount of fentanyl in other medicines that contain fentanyl. Your healthcare provider will prescribe a starting dose of ABSTRAL that may be different than other fentanyl containing medicines you may have been taking.
The possible side effects of ABSTRAL:
  • Constipation, nausea, sleepiness, vomiting, tiredness, headache, dizziness, abdominal pain, low red blood cell count, swelling of the arms, hands, legs and feet. Call your healthcare provider if you have any of these symptoms and they are severe.
  • Decreased blood pressure. This can make you feel dizzy or lightheaded if you get up too fast from sitting or lying down.
  • Pain, irritation, or sores at the application site (on your gum, on the inside of your cheek, or under your tongue). Tell your healthcare provider if this is a problem for you.
Get emergency medical help if you have:
  • Trouble breathing, shortness of breath, fast heartbeat, chest pain, swelling of your face, tongue, or throat, extreme drowsiness, light-headedness when changing positions, feeling faint, agitation, high body temperature, trouble walking, stiff muscles, or mental changes such as confusion.
  • These symptoms can be a sign that you have taken too much ABSTRAL or the dose is too high for you. These symptoms may lead to serious problems or death if not treated right away. If you have any of these symptoms, do not take any more ABSTRAL until you have talked to your healthcare provider.
  • These are not all the possible side effects of ABSTRAL. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088, or to Sentynl at 888-227-8725. Additional information may also be found at http://dailymed.nlm.nih.gov.
  • Abstral® is a federally controlled substance (CII) available by prescription only. This information is not intended to replace discussions with your doctor.
    Please see Full Prescribing Information, with Boxed Warning and Medication Guide.